MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD GREEN

Model Number	48360G-10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while transecting the rectum during a da vinci-assisted lower anterior resection (lar) procedure, a partial fire occurred with a green sureform 60 reload installed on a sureform 60 stapler instrument.This occurred on the first and second firing of the stapler instrument and a new stapler reload was used to continue and complete the procedure robotically.The firing issue did not result in bleeding.The customer reported that there were holes/gaps in the staple line.No hard objects, or previous staple lines were stapled over and no buttress material was used.The customer states the issue was not with the instrument, but with the reload(s).
Additional Manufacturer Narrative
The two green sureform 60 reloads associated with the complaint have been returned and failure analysis has been completed.Though the order the stapler reloads were fired is not able to be determined, the stapler reload captured under the first fire was found to have the knife exposed within the knife track towards the distal end.Also, the stapler reload was found to have cartridge damage.The sides of the stapler reload showed cartridge damage.The piece was removed from in between the stapler reload and the shuttle was fully deployed.The knife was inspected and there was no damage found.The second stapler reload was also found to have the knife exposed within the knife track, but towards the proximal end.Additionally, the stapler reload was found to have cartridge damage.The top of the stapler reload showed damage to the cartridge.The piece was removed from in between the reload and the shuttle was fully deployed.The knife was inspected and there was no damage found.Due to insufficient procedural information, further system/instrument log investigation cannot be performed.Note: refer to medwatch reports (mdr) with mfr report #2955842-2025-11273 for mdr submission of the events logged against first green sureform 60 reload fire.
Additional Manufacturer Narrative
Updated section: b3.Additional information: an advance stapler log review shows the sureform 60 stapler instrument, (lot number: k12241107-0258), was installed on the system 4 times and fired 4 green reloads.On install 1, the first two clamps were incomplete.The 3rd clamp was successful, and the firing was completed with 2 pauses for compression.On install 2, the first clamp was incomplete.The next clamp was successful but was followed by a firing failure.On install 3, the first clamp was successful, but was followed by a second firing failure.On install 4, the system failed to detect the reload color and the user manually selected the green reload via the surgeon side console touchpad.The first clamp was successful but was followed by a third firing failure.There were no stapler related errors in the logs.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD GREEN
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 21699382
• Report Number: 2955842-2025-11272
• Device Sequence Number: 18142666
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360G-10
• Device Catalogue Number: 48360G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown